UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051263 |
|---|---|
| Receipt number | R000058461 |
| Scientific Title | Study of determinant factors of anaerobic threshold (AT) assessed by cardiopulmonary test (CPX) in patients undergoing cardiac rehabilitation |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/05 13:19:07 |
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Basic information
Public title
Study of determinant factors of anaerobic threshold (AT) assessed by cardiopulmonary test (CPX) in patients undergoing cardiac rehabilitation
Acronym
Determinant factor of AT
Scientific Title
Study of determinant factors of anaerobic threshold (AT) assessed by cardiopulmonary test (CPX) in patients undergoing cardiac rehabilitation
Scientific Title:Acronym
Determinant factor of AT
Region
| Japan |
Condition
Condition
patients with cardiac disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to clarify the determinant factors of anaerobic threshold (AT) assessed by cardiopulmonary test (CPX) in patients undergoing cardiac reghabilitation
Basic objectives2
Others
Basic objectives -Others
To investigate whethet determinant factor of anaerobic threshold (AT) is muscle mass.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the determinant factors of anaerobic threshold (AT)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing cardiac rehabilitation
Key exclusion criteria
patients who could no be performed cardiopulmonary test (CPX)
patients whom doctors judged inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Minatoguchi |
Organization
Gifu Municipal Hospital
Division name
Cardiology
Zip code
500-8513
Address
7-1 Kashimachou
TEL
058-251-1101
minatoguchi.shinya.g7@a.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Minatoguchi |
Organization
Gifu Municipal Hospital
Division name
cardiology
Zip code
500-8513
Address
7-1 kashimacyou, Gifu
TEL
058-251-11011
Homepage URL
minatoguchi.shinya.g7@a.gifu-u.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Municipal hospital
Address
7-1 kashimacyou gifu
Tel
0582511101
minatoguchi.shinya.g7@a.gifu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At present enrollment is going on
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058461
